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  5. Label Information: Help I Have Allergies

FDA Label for Help I Have Allergies

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. WARNINGS
    4. OTC - KEEP OUT OF REACH OF CHILDREN
    5. OTC - PREGNANCY OR BREAST FEEDING
    6. DOSAGE & ADMINISTRATION
    7. INDICATIONS & USAGE
    8. INACTIVE INGREDIENT
    9. OTC - QUESTIONS
    10. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Help I Have Allergies Product Label

The following document was submitted to the FDA by the labeler of this product Help Remedies, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active Ingredient                                 Purpose
(in each tablet)

Loratadine 10mg..........................................Antihistamine



Otc - Purpose



Use

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies
  • runny nose
  • itchy, watery eyes
  • itching of the nose or throat
  • sneezing



Warnings




Warnings

Do not use ifyou have ever had an allergic reaction to this product or any of its ingredients


Ask a doctor before use if you have
  • liver or kidney disease
  • your doctor should determine if you need a different dose
    • When using this product do not take more than directed.Taking more than directed may
    cause drowsiness.

    Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical
    help right away.

Otc - Keep Out Of Reach Of Children



Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control
Center right away.


Otc - Pregnancy Or Breast Feeding



If pregnant or breast feeding, ask a health professional before use.

Dosage & Administration




Directions
  • adults and children 6 years and over: 1 tablet daily; not more than 1 tablet in 24 hours
  • children under 6 years of age: ask a doctor
  • consumers with liver or kidney disease: ask a doctor

Indications & Usage



Other Information

  • do not use if individual blister is open or torn
  • store between 20-25 degrees celcius (68-77 degrees fahrenheits)
  • protect from excessive moisture
  • use by expiration date on package
  • keep carton. They contain important information.

Inactive Ingredient



Inactive Ingredientscorn starch, lactose monohydrate, magnesium stearate,pregelatinized starch

Otc - Questions



Distributed by Help Remedies,
57 W. 28th St. Fl. 4
New York, NY 10001
www.helpineedhelp.com


Package Label.Principal Display Panel



HelpAllergiesLabel - HelpAllergies

HelpAllergiesLabel - HelpAllergies


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